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Trial record 1 of 1 for:    NCT01551212
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Efficacy of Everolimus in Combination With Tacrolimus in Liver Transplant Recipients (HEPHAISTOS)

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ClinicalTrials.gov Identifier: NCT01551212
Recruitment Status : Completed
First Posted : March 12, 2012
Results First Posted : May 10, 2019
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This trial evaluated the efficacy and safety of Everolimus in combination with tacrolimus versus a standard immunosuppressive regimen concerning kidney function in liver transplant recipients.

Condition or disease Intervention/treatment Phase
Liver Transplantation Drug: Everolimus Drug: Tacrolimus Drug: Corticosteroids Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 339 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 12-month, Multi-center, Open-label, Randomized, Controlled Study to Evaluate Efficacy/Safety and Evolution of Renal Function of Everolimus in Co-exposure With Tacrolimus in de Novo Liver Transplant Recipients
Actual Study Start Date : May 24, 2012
Actual Primary Completion Date : August 8, 2017
Actual Study Completion Date : August 8, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EVR/TAC
Tacrolimus minimization arm. Everolimus (C0-h: 3-8 ng/mL) + tacrolimus (C0-h: < 5 ng/mL)
Drug: Everolimus
tablet containing 0.25mg, 0.5mg, 0.75mg or 1.0mg
Other Name: RAD001 / Certican

Drug: Tacrolimus
capsule containing 0.5, 1.0, or 5.0mg
Other Name: Tacrolimus Hexal

Drug: Corticosteroids
For patients in all groups, corticosteroids were initiated at or prior to the time of transplantation according to local practice. Corticosteroids may have been used for the duration of the study according to the investigator`s discretion, but may not have been eliminated sooner than 6 months post-transplantation.

Active Comparator: TAC
Tacrolimus (C0-h: 6-10 ng/ml)
Drug: Tacrolimus
capsule containing 0.5, 1.0, or 5.0mg
Other Name: Tacrolimus Hexal

Drug: Corticosteroids
For patients in all groups, corticosteroids were initiated at or prior to the time of transplantation according to local practice. Corticosteroids may have been used for the duration of the study according to the investigator`s discretion, but may not have been eliminated sooner than 6 months post-transplantation.




Primary Outcome Measures :
  1. Estimated Glomerular Filtration Rate (GFR) [ Time Frame: month 12 ]
    The estmated GFR was calculated using MDRD-4 formula (Modification of Diet in Renal Disease Study Group).


Secondary Outcome Measures :
  1. Estimated GFR - PP Set [ Time Frame: month 12 ]
    This was a sensitivity analysis for the primary outcome measure based on the per-protocol set of patients.

  2. Percentage of Participants With Treated Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death [ Time Frame: 12 months ]
    Percentage of Participants with Treated Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death at Month 12

  3. Number of Participants With HCV [ Time Frame: 12 months ]
    Number of Participants with HCV (hepatitis C virus) assessed as treatment emergent adverse events of special interest

  4. Incidence of HCV Related Fibrosis [ Time Frame: 12 months ]
    Incidence of hepatitis C virus (HCV) related fibrosis assessed as treatment emergent adverse events of special interest

  5. Incidence of de Novo HCC Malignancies [ Time Frame: 12 months ]
    Incidence of de novo Hepatocellular Carcinoma (HCC) malignancies assessed as treatment emergent adverse events of special interest

  6. Incidence and Severity of CMV Viral Infections. [ Time Frame: 12 months ]
    Incidence and severity of cytomegalovirus (CMV) viral infections assessed as treatment emergent adverse events of special interest.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Male or female recipients of a full-size liver allograft, aged 18 to 65 years.

Exclusion criteria:

Patients with thrombocytopenia (platelets <50,000/mm³), with an absolute neutrophil count of <1,000/mm³ or leucopenia (leucocytes <2000/mm³), with anemia with Hb < 6g/dl at time of randomization

Patients with uncontrolled hypercholesterolemia (>350mg/dL; >9mmol/L) or hypertriglyceridemia (>750 mg/dL; >8.5 mmol/L) at time of randomization

History of malignancy of any organ system within the past 5 years whether or not there is evidence of local recurrence or metastases, other than non-metastatic basal or squamous cell carcinoma of the skin or HCC


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01551212


Locations
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Germany
Novartis Investigative Site
Aachen, Germany, 52074
Novartis Investigative Site
Berlin, Germany, 13353
Novartis Investigative Site
Bonn, Germany, 53105
Novartis Investigative Site
Erlangen, Germany, 91052
Novartis Investigative Site
Essen, Germany, 45147
Novartis Investigative Site
Frankfurt, Germany, 60590
Novartis Investigative Site
Hamburg, Germany, 20246
Novartis Investigative Site
Hannover, Germany, 30625
Novartis Investigative Site
Heidelberg, Germany, 69120
Novartis Investigative Site
Kiel, Germany, 24105
Novartis Investigative Site
Leipzig, Germany, 04103
Novartis Investigative Site
Mainz, Germany, 55131
Novartis Investigative Site
Munchen, Germany, 81377
Novartis Investigative Site
Regensburg, Germany, 93053
Novartis Investigative Site
Tübingen, Germany, 72076
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Study Protocol  [PDF] August 19, 2015
Statistical Analysis Plan  [PDF] November 6, 2017


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01551212     History of Changes
Other Study ID Numbers: CRAD001HDE13
2011-003118-17 ( EudraCT Number )
First Posted: March 12, 2012    Key Record Dates
Results First Posted: May 10, 2019
Last Update Posted: May 10, 2019
Last Verified: May 2019
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Liver transplantation
Everolimus
Tacrolimus
Renal function
Additional relevant MeSH terms:
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Sirolimus
Everolimus
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents